|
IPC to come out with10th edition of IP to further strengthen standards of drugs in India
|
|
Shardul Nautiyal, Mumbai
December 09 , 2025
|
|
|
In order to further strengthen the standards of drugs in India, the Indian Pharmacopoeia Commission (IPC) is coming out with the publication of 10th edition of the Indian Pharmacopoeia (IP 2026). The same will be ready for its release on January 02, 2026 by the Union minister of health and family welfare J P Nadda, so as to become effective from July 1, 2026. A transition period of 6 months shall be provided to the stakeholders for adoption of the IP 2026 standards.
IP prescribes the official standards for drugs manufactured and/or marketed in India.
The IP is published by the IPC on behalf of the ministry of health and family welfare, Government of India to fulfil the requirements of the Drugs and Cosmetics (D&C) Act, 1940 and Rules 1945 thereunder.
IPC has the mandate to publish IP editions on regular basis with inclusion of new drug standards along with revision of existing standards so that they intend to meet the current requirements.
IP-2026 contains a total of 121 new monographs including 88 drug substances, dosage forms, and pharmaceutical aids, 05 vitamins, minerals, amino acids, fatty acids etc., 02 biotechnology derived therapeutic products, 03 human vaccines, 02 blood related products, 20 blood and blood component monographs, and 01 veterinary vaccines monographs. This will lead to the total number of 3340 monographs in the IP.
In addition, 05 new general chapters have also been introduced. Further, 18 general chapters and 22 excipient monographs are harmonized with the Pharmacopoeial Discussion Group (PDG) pharmacopoeias (i.e. European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and United States Pharmacopoeia (USP). IP-2026 will be released in both physical hard bound as well as online subscription format.
The earlier 9th edition of the IP was released during IPC Conference 2022 in New Delhi.
IP 2022 contained a total of 92 new monographs including 60 chemical, 21 vitamins, minerals, amino acids, fatty acids etc., 3 biotechnology-derived therapeutic products, 4 human vaccines, 2 blood and blood related products, 2 herbs and herbal related products, and 7 phytopharmaceutical ingredient category monographs. This had led to the total number of 3152 monographs in the 9th edition of IP. In additions, 12 new general chapters were also introduced. Several monographs and general chapters had also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like USP, JP, EP, British Pharmacopoeia (BP) etc. The harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries.
|
|
|
|
|
|
|
|
TOPICS
|
The Food and Drug Administration (FDA), Maharashtra, has issued a public advisory urging citizens to report any misleadi ...
|
|
|
|
|